Samsung Bioepis has secured a further approval for its Byooviz (ranibizumab) biosimilar rival to Lucentis, from Health Canada. The approval follows previous nods in the US and EU as well as the UK last year for the groundbreaking ophthalmic biosimilar, previously known as SB11. (Also see "FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival" - Generics Bulletin, 20 September, 2021.)
Canada Gives Samsung Bioepis A Further Ranibizumab Approval
Health Canada Nod For Byooviz Lucentis Rival Follows US And EU
Samsung Bioepis has racked up a further endorsement for its Byooviz biosimilar ranibizumab, after Health Canada approved the rival to Lucentis.

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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.
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With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.
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